Devices

Device Recall Tecan Genesis

  • 모델명 / 제조번호(시리얼번호)
    PN 10-410 Tecan Genesis 150/8 Back End Configuration,  PN 10-415 Tecan Genesis 150/8 Front End Configuration, PN 10-309 Tecan Genesis 200/8 Workstation, PN 10-307 Tecan Genesis 150/8 Workstation, PN 10-043A Tecan Genesis RSP 150/8, PN 10-040A Tecan Genesis RSP 100/4, PN 10-401A Tecan Genesis RSP 100/8,
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    CA, CT, GA, IL, IN, MA, MD, MI, NJ, NY, PA, TN, TX, VA, & WI.
  • 제품 설명
    Tecan Clinical Workstations with Robonet software
  • Manufacturer
    Tecan U S Inc
  • 1 Event

제조사

Tecan U S Inc
  • 제조사 주소
    Tecan U S Inc, 4022 Stirrup Creek Rd,Ste310, Durham NC 27709
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건

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Device Recall Tecan Genesis Instruments
  • 모델명 / 제조번호(시리얼번호)
    Genesis 100, 150 &200, Tecan PosID2 units with firmware version 2.5 or lower
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Instruments requiring upgrade were distributed to various clinical laboratories and blood banks Nationwide and World wide .
  • 제품 설명
    Tecan Genesis RSP and NPS Instruments with barcode scanner type PosID2 option with firmware version 2.45 or lower.
  • Manufacturer
    Tecan U S Inc
Device Recall Tecan Genesis
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers 5524, 6177, 6224, 6376, 6393, 6395, 6397, 6557, 7150, 7349, 7350, 7594, 7616 and 7724.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide. California, Connecticut, Georgia, Illinois, Indiana, Maryland, Massachusetts, Michigan, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Wisconsin.
  • 제품 설명
    Tecan clinical workstation; Tecan Genesis 150 front end, Roche catalog number 03585379001.
  • Manufacturer
    Roche Diagnostics Corp.